Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

Stopped early · Phase 2

Conditions studied: Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer

In brief

To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Key facts

Study ID

NCT01851174

Run by

Western Regional Medical Center

People needed

15

Starts

2013-02-01

Expected to finish

2015-01-01

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
• Patient has one or more radiographically measurable tumor.
• Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
• Age ≥ 18 years.
• Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
• ECOG performance status 0 - 2 and an expected survival of at least 3 months.
• Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Hemoglobin (Hgb) ≥ 9g/dl
• Patients with adequate organ function as measured by:
• A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
• B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.
• C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease.
• Women must meet one of the following criteria:
• Post-menopausal for at least one year
• Surgically incapable of child-bearing
• Utilizing a reliable form of contraception for the duration of study participation. Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration.

You may not qualify if…

• Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
• Previous use of any chemotherapy or radiation therapy for metastatic disease.
• Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
• Other significant active or chronic infection.
• History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
• Pregnant or nursing females.
• Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
• Major surgery, other than diagnostic surgery within 4 weeks of study entry.
• Patient requires a legal authorized representative for consenting.

Where it is running

• Western Regional Medical Center — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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